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Microbiologist

Carlow
Pe Global
Posted: 12h ago
The role
PE Global is currently recruiting for a Micro Specialist for a leading multi-national Pharma client based in Carlow.This is a contract position.Role:My client a global multi national pharma company is seeking an Associate Specialist Quality Control to provide technical support to the QC Microbiology Lab & operations to ensure the continued manufacture and supply of quality pharmaceutical products in meeting the priorities of: Compliance, Supply, Strategy and Profit Plan. This role is integral to our manufacturing division and requires a high level of leadership, initiative, collaboration, and coaching to facilitate the team in becoming a high-performance organization. If you are passionate about driving continuous improvement and delivering technical excellence, we invite you to join our company and make a difference in advancing health solutions.ResponsibilitiesSupporting the environmental control program by trend analysis and implementation of appropriate corrective and preventative measures.Supporting and owner of Environmental monitoring risk assessments and qualification.Generation of quarterly and annual trend reports.Understanding and applying regulatory/compliance and compendial requirements to their role together with remaining current on upcoming regulatory and compliance changes.Development and execution of Microbiology test methods and project validations.Troubleshooting of issues which arise during the execution of validation studies and routine tests.Development of training modules.Microbiology Support to Site Investigations and projects relating to environmental monitoring and utilities monitoring.Driving Continuous Improvement initiatives, including lean lab initiatives, method optimization/redevelopment.Authoring and managing change controls, procedures, test methods and deviations.Result authorization for microbiological samples to support batch release.GLIMS System updates.Assessing compendial and quality manual updates pertaining to the Microbiology Lab & environmental control.Supporting lab stock management and financial control as required.Interpreting customer needs, assessing requirements, and identifying solutions to non-standard requests.Making decisions within guidelines and policies which impact microbiology projects.Ensuring highest safety standards.Performing other duties as assigned.RequirementsBachelor’s degree in Microbiology, Biology, Biotechnology, Pharmaceutical Science, or a related Life Sciences field.Minimum 3 years of hands‑on experience in microbiology/QC, specifically in environmental monitoring and utilities monitoring, supporting site projects, trending, risk assessments, and data analysis.Familiarity with ALCOA(+) data integrity principles, electronic laboratory systems, and controlled documentation.Entry- to early-career level with growing technical competence; able to perform routine tasks with limited discretion.
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